SmartWatch ECG Evaluation Trial I

NCT05942274 | Withdrawn DMC FDA Device

• 1 other identifier: 16143
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, non-randomized study to collect validation data for submission to the Food and Drug Administration (FDA) to support a 510(k) device clearance for a smartwatch ECG.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• QRS amplitude

  Recordings will be acquired from the other models of the Smartwatch as well as a recording utilizing the FDA-cleared KardiaMobile.

  30 seconds

Study Arms (1)

Screen group

EXPERIMENTAL

This is a single-center, non-randomized open study with a single-patient clinical trial design (i.e., the patients serve as their own control).

Diagnostic Test: We propose to validate these smartwatch ECG functions to support FDA submissions

Interventions

We propose to validate these smartwatch ECG functions to support FDA submissions DIAGNOSTIC_TEST

1\) Obtain a simultaneous recording of a Lead I (RA-LA) ECG from the Smartwatch and a clinical standard device (GE Cardiosoft ECG). Subsequent recordings will be acquired from the other models of the Smartwatch as well as a recording utilizing the FDA-cleared KardiaMobile.

Screen group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female \> 18 years of age.
• Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
• Being seen in the OU Cardiac Electrophysiology Outpatient Clinic.

You may not qualify if:

• Inability or refusal of the patient and/or the patient's legally acceptable representative to provide written informed consent for any reason.
• Other conditions that in the opinion of the Lead Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stavros Stavrakis, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We propose to validate these smartwatch ECG functions to support FDA submissions

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 12, 2023
• Study Start: December 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: April 18, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)